Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

24776–24800 of 26084

SevereFDA (Drugs)·D-0730-2021·2021-08-25
DAUNOrubicin Hydrochloride Injection Recalled Due to Sterility Assurance
Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL due to lack of assurance of sterility. The recall affects 1,351 vials distributed nationwide, including Puerto Rico.
Product
DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0741-2021·2021-08-25
Metoclopramide Injection Vials Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.
Product
METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0745-2021·2021-08-25
Octreotide Acetate Injection 50 mcg/mL Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 50 mcg/mL in single-dose vials due to lack of assurance of sterility. The recall affects specific lots distributed nationwide, including Puerto Rico.
Product
Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0911-2021·2021-08-25
HiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling
Able Groupe Inc is recalling HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling statements.
Product
HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0734-2021·2021-08-25
Idarubicin Hydrochloride Injection Recalled Due to Sterility Concerns
Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL vials nationwide due to lack of assurance of sterility. The recall affects 2,091 vials distributed across the United States and Puerto Rico.
Product
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0736-2021·2021-08-25
Teva Octreotide Acetate Injection Recalled for Sterility Assurance Failure
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.
Product
Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0743-2021·2021-08-25
Methylprednisolone Acetate Injectable Suspension recalled for sterility concerns
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials distributed nationwide, including Puerto Rico.
Product
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2244-2021·2021-08-25
Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect
Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.
Product
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0748-2021·2021-08-25
Adenosine Injection Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.
Product
Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0907-2021·2021-08-25
HiPP Comfort Milk Formula Recalled for Inadequate Iron and Labeling Violations
Able Groupe Inc is recalling HiPP Comfort Milk Formula because some products contain insufficient iron and lack required labeling. The formula may not provide adequate iron for certain infants, particularly premature or low-birth-weight infants.
Product
HiPP Comfort Milk Formula
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2318-2021·2021-08-25
CT X-ray System Software Miscalculates Contrast Volume with Pounds Unit Setting
Philips 728333 Spectral CT 7500 systems with SynchRight software may incorrectly calculate and recommend increased contrast volume when patient weight is set to pounds. Affected system should be updated to prevent excess contrast dosing.
Product
728333 Spectral CT 7500 -Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2307-2021·2021-08-25
Oxygen Sensors in Incubators May Display Inaccurate Readings
CooperSurgical oxygen sensors in incubators may display inaccurate oxygen readings that do not trigger alarms when discrepancies occur. This could result in loss of embryos during storage.
Product
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standa
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2317-2021·2021-08-25
IQon Spectral CT System Software Error Increases Contrast Volume
Philips IQon Spectral CT systems can recommend excessive contrast volume when patient weight is set to pounds due to a SynchRight software calculation error, potentially resulting in patient overdose.
Product
728332 IQon Spectral CT-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2311-2021·2021-08-25
Cell Marque Antibody Reagents Recalled for Incorrect Expiry Date Labeling
Cell Marque antibody reagents used in pathology are recalled for labeling an incorrect expiry date (December 31, 2023 instead of December 31, 2022). Using expired reagent may result in weak or absent staining and false negative test results.
Product
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0740-2021·2021-08-25
Adenosine Injection Vials Recalled for Sterility Assurance Failure
Teva Pharmaceuticals is recalling Adenosine Injection, USP 60mg/20mL vials nationwide due to lack of assurance of sterility. The recall affects 4,249 vials distributed nationwide, including Puerto Rico.
Product
Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0908-2021·2021-08-25
HiPP AR Germany Anti-Reflux Infant Formula Lacks Required FDA Approval and Labeling
Able Groupe Inc is recalling HiPP AR Germany Anti-Reflux Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English labeling required by federal regulations.
Product
HiPP AR Germany Anti-Reflux Milk Formula
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2299-2021·2021-08-25
I.V. Catheter Recall: Sterilization Defects in NEO DELTA Self Safe Devices
Delta Med is recalling 10,000 units of NEO DELTA Self Safe I.V. Catheters due to sterilization defects. Affected devices were distributed in Florida and Minnesota.
Product
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2306-2021·2021-08-25
Philips EPIQ Ultrasound Systems Control Panel Arm Swivel Lock May Fail
Philips EPIQ ultrasound system control panel arm swivel locks can fail, allowing the monitor to swivel freely during positioning or transport, potentially causing user or patient musculoskeletal injury.
Product
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2301-2021·2021-08-25
NEO DELTA Self Safe T IV Catheters Recalled for Sterilization Failure
NEO DELTA Self Safe T IV catheters may lack sterility due to sterilization problems. The FDA is recalling 20,000 units distributed in Florida and Minnesota.
Product
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2290-2021·2021-08-25
Trilogy Evo Respiratory Device Recalled for Software Pressure Issues
Philips Respironics has recalled Trilogy Evo Universal respiratory devices (model DS2000X11B) for software defects that increase pressure, particularly in pediatric and infant applications.
Product
Trilogy Evo Universal, Product number DS2000X11B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2303-2021·2021-08-25
IV Catheters Recalled by FDA for Sterilization Defects
Delta Med is recalling NEO DELTA SELFSAFE PUR T IV catheters due to possible sterilization failures. The recall affects 14,000 units distributed in Florida and Minnesota.
Product
NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2289-2021·2021-08-25
Trilogy EV300 Ventilator Recalled for Software-Related Pressure Calibration Issues
Philips Respironics is recalling the Trilogy EV300 ventilator due to software issues causing pressure calibration errors affecting infant and pediatric patients. The defects impact 18,936 units distributed in the United States.
Product
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0867-2021·2021-08-25
Moonwalk 70% Dark Chocolate Bar Recalled for Undeclared Milk
Cocanu LLC is recalling Moonwalk 70% dark chocolate bars because milk is not declared on the label, even though lactose is present. The product may pose a risk to consumers with milk allergies.
Product
Moonwalk 70% dark chocolate bar. It is packaged in white shiny paper with blue print. Net Weight: 1.2 oz / 35gr. No UPC. The label is read in parts: "***Moonwalk ***a 70% dark chocolate bar ***chocolate, cacao nibs and pop rocks ***Contents: cacao beans, cacao butter, cane sug
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2288-2021·2021-08-25
Trilogy Evo O2 Ventilator Software Issues Affecting Pressure Delivery
Philips Respironics is recalling Trilogy Evo O2 ventilators with software issues that can increase pressure delivery. One issue affects infant/pediatric settings; another causes pressure drift during continuous use.
Product
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2325-2021·2021-08-25
Evexia Luxe DVT Prevention Device Recalled for Marketing Without FDA Clearance
Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.
Product
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
Category
Medical Device
Distribution
Distributed nationwide

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24776–24800 of 26084